1        INTRODUCTION

1.1     The purpose of this protocol is to set out ELMS approach to consent and the way in which the principles of consent will be put into practice.

It is not a detailed legal or procedural resource due to the complexity and nature of the issues surrounding consent.

In an out of hours’ setting the presentation of cases are usually for urgent medical conditions, usually treatment is immediate and necessary or the consultation ends in a rapid referral to hospital.   By nature of presentation the process of consent is limited to those patients who are children or are vulnerable.   Out of hours’ services do not perform investigations, immunisations or invasive procedures; therefore, this protocol is limited to face-to-face presentations.

1.2     Where possible, a clinician must be satisfied that a patient understands and consents to a proposed treatment / examination.   This will include the nature, purpose, and risks of the procedure (see 1.1), if necessary by the use of drawings, interpreters, videos or other means to ensure that the patient understands, and has enough information to give ‘Informed Consent’.

 

2        IMPLIED CONSENT

2.1     In the NHS, implied consent is assumed for many routine physical contacts with patients, including ELMS services where referrals are made via NHS 111, the ambulances service or other health care providers who will have already obtained patient consent.

2.2       Implied Consent is where the patient has not been specifically asked if they wish to share or not share their information/record but the permission is set in the system to allow the sharing to happen.   There are circumstances where implied consent will be applied to patients’ records, either individually or as a whole group, in the best interest of patient care and is usually done by a clinician who feels it in the patients best interests because they have care needs or mental incapacity.

2.3     In all cases where implied consent is assumed by the clinician, the following will apply:

·        An explanation will be given to the patient what he / she is about to do, and why.

·        The explanation will be sufficient for the patient to understand the nature of the consultation.

·        In all cases where the patient is under 18 years of age a verbal confirmation of consent will be obtained and entered into the medical record.

·        Where there is a significant risk to the patient an “Expressed Consent” will be obtained in all cases (see below).

 

3        EXPRESSED CONSENT

3.1     Expressed consent (written or verbal) will be obtained for any intervention which carries a risk that the patient is likely to consider as being substantial or a risk/side effect that is commonly occurring.   A note will/should be made in the medical record detailing the discussion about the consent and the risks.   A Consent Form (see attached) may be used for the patient to express consent (see below).

 

4        OBTAINING CONSENT

4.1     The clinician should take account of the following:

·        Consent (Implied or Expressed) will be obtained prior to the consultation, and any treatment steps arranged for the patient.   This includes the issuing of prescriptions and onwards referral to other care services for other treatments, procedures, sedation etc.

·        The clinician will ensure that the patient has competency to provide a consent (16 years or over) or has “Gillick Competence” if under 16 years.   Further information about Gillick Competence and obtaining consent for children is set out below.

·        Consent will include the provision of all information relevant to the treatment.

·        Questions posed by the patient will be answered honestly, and information necessary for the informed decision will not be withheld unless there is a specific reason to withhold.   In all cases where information is withheld then the decision will be recorded in the clinical record.

·        The person who obtains the consent will be the person who carries out the consultation.

·        The person obtaining consent will be fully qualified and will be knowledgeable about the procedure and the associated risks, that might be carried out because of onwards referral (ELMS do not carry out invasive procedures).

·        The scope of the authority provided by the patient will not be exceeded unless in an emergency.

·        The service acknowledges the right of the patient to refuse consent, delay the consent, seek further information, limit the consent, or ask for a chaperone.   

ELMS Privacy Notice document is available to the clinician and the patient.  This document explains how ELMS looks to use patient information in support of patient care.

·        Clinicians may use a Consent Form (see attached) where procedures carry a degree of risk or where, for other reasons, they consider it appropriate to do so (e.g. malicious patients).      

·        No alterations will be made to a Consent Form once it has been signed by a patient.

·        Clinicians will ensure that consents are freely given and not under duress (e.g. under pressure from other present family members etc.).

 ·        If a patient is mentally competent to give consent but is physically unable to sign the Consent Form (see attached), the clinician should complete the Form as usual, and ask an independent witness to confirm that the patient has given consent orally or non-verbally.

4.2     Other aspects, which may be explained by the clinician, include:

·        Details of the diagnosis, prognosis, and implications if the condition is left untreated

·        Options for treatment, including the option not to treat.

·        Details of any subsidiary treatments (e.g. pain relief)

 

5        CONSENT FOR CHILDREN

5.1     Everyone aged 16 or more is presumed to be competent to give consent for themselves, unless the opposite is demonstrated.   If a child under the age of 16 has “sufficient understanding and intelligence to enable him/her to understand fully what is proposed” (known as Gillick Competence), then he/she will be competent to give consent for him/herself.

Young people aged 16 and 17, and legally ‘competent’ younger children, may therefore sign a Consent Form, for themselves, but may like a parent to countersign as well.   For children under 16 (except for those who have Gillick Competence as noted above), someone with parental responsibility should give consent on the child’s behalf by signing accordingly on the Consent Form.